Eur J Anaesthesiol 2019; 36:955–962

ORIGINAL ARTICLE

Laryngeal Mask Airway Supreme vs. the Spritztube

tracheal cannula in anaesthetised adult patients
A randomised controlled trial
Silvia De Rosa, Antonio Messina, Massimiliano Sorbello, Alessandro Rigobello,
Davide Colombo, Anna Piccolo, Efrem Bonaldi, Paolo Gennaro, Violeta Urukalo,
Downloaded from https://journals.lww.com/ejanaesthesiology by BhDMf5ePHKav1zEoum1tQfN4a+kJLhEZgbsIHo4XMi0hCywCX1AWnYQp/IlQrHD3q7dCwSUxuLjK502v8aTgG9wbxeElyXzstbTWviKHA4g= on 11/14/2019

Adriano Pellizzari, Raffaele Bonato and Stefano Checcacci Carboni

BACKGROUND The Spritztube is a new supraglottic airway
device combining the ability to allow extraglottic ventilation of
the lungs with the opportunity to perform fibreoptic-assisted
intubation.
OBJECTIVES To compare the Spritztube tracheal cannula
with the Laryngeal Mask Airway Supreme (LMA-S) in anaes-
thetised adult patients.
DESIGN A single-centre, randomised controlled study.
SETTING Tertiary hospital.
PATIENTS Mechanically ventilated patients undergoing
elective surgery in the supine position under general anaes-
thesia were included. Main exclusion criteria were a history
of, or predicted, difficult airway management according
to SIAARTI guidelines and absence of written informed
consent.
INTERVENTIONS Patients received the LMA-S or Spritz-
tube tracheal cannula to facilitate ventilation of the lungs.
attempts, subjective assessment of ease of insertion, safety
and incidence of complications were recorded.
RESULTS One hundred and sixty seven patients were allo-
cated to the LMA-S or Spritztube group, respectively, a total of
334 patients. In the LMA-S group, the device insertion failed in
nine patients, compared with none in the Spritztube group
(P ¼ 0.002). Spritztube insertion was easy in 100% of cases
compared with 94.6% of the cases in the LMA-S group
(P ¼ 0.03). The number of attempts was significantly higher
with the LMA-S compared with the Spritztube (P ¼ 0.0007),
whereas the insertion times were comparable (P ¼ 0.06).
Except for the incidence of blood-staining, which was higher
in the LMA-S group (P ¼ 0.01), the number of complications
was comparable in the two groups.
CONCLUSION The Spritztube was as effective as the LMA-
S in maintaining the airway with all patients being success-
fully ventilated without difficulty. The success rate of achiev-
ing a patent airway was comparable between the groups,
with a similar occurrence of complications.

MAIN OUTCOME MEASURES Successful placement TRIAL REGISTRATION NCT03443219.

(primary outcome), time required for insertion, number of Published online 18 October 2019

Background
Supraglottic airway devices [Laryngeal Mask Airway
(LMA); Teleflex Medical, Athlone, Ireland] are specific
airway devices now used commonly for airway maintenance
during general anaesthesia for different elective procedures.
Airway management guidelines suggest their use for rescue
ventilation during difficult airway management.1–3
In addition, they are used as an airway conduit for
endotracheal intubation either blindly or preferably with
fibreoptic assistance. The first, and probably most com-
monly used, supraglottic airway device is the laryngeal
mask airway, consisting of a hollow tube connected to an
anatomically shaped cuff designed to fit the hypopharynx

From the Department of Anaesthesiology and Intensive Care, San Bortolo Hospital, Vicenza (SDR, AR, AP, EB, PG, VU, AP, RB, SCC), Department of Anaesthesia and
Intensive Care Medicine, Maggiore Della Carità University Hospital, Novara (AM, DC) and Anesthesia and Intensive Care, AOU Policlinico Vittorio Emanuele, Catania, Italy
(MS)
Correspondence to Massimiliano Sorbello, MD, Anaesthesia and Intensive Care, AOU Policlinico Vittorio Emanuele, Catania, Italy
Tel: +39 3496277107; e-mail: maxsorbello@gmail.com

0265-0215 Copyright ß 2019 European Society of Anaesthesiology. All rights reserved. DOI:10.1097/EJA.0000000000001106

Copyright © European Society of Anaesthesiology. Unauthorized reproduction of this article is prohibited.

 956 De Rosa et al.
facing the glottis, with its tip sealing the upper
oesophageal sphincter.
Further evolutions have been provided over the years,
including the intubating laryngeal mask (iLMA – Fas-
trach; Teleflex Medical), and so-called second-genera-
tion devices, allowing gastric access and increased sealing
capabilities, and newer devices with advanced airway
protection features and intubation possibility.3 The
LMA Supreme (LMA-S; Teleflex Medical) is a second
generation polyvinyl chloride (PVC) single-use device
with gastric access and not primarily designed for intu-
bation, and has been shown to be particularly safe, easy to
use and effective.4
Recently, a new supraglottic airway device, the Spritz-
tube tracheal cannula (Med Europe s. r. l, Aulla, Italy) was
developed in our centre at the Department of Anaesthe-
sia and Intensive Care, San Bortolo Hospital, Vicenza,
with specific features combining the ability to perform
both supraglottic airway device ventilation and fibreop-
tic-guided tracheal intubation using the same device.5
The Spritztube consists of a silicone cannula with two
low-pressure cuffs: a proximal cuff, designed to seal the
pharynx cranially in respect of the epiglottis, and a distal
cuff designed to seal the oesophagus. The positioning of
this device requires the aid of a dedicated stilette,
designed to align the two cuffs while stiffening the
Spritztube so as to allow passage through the oropharynx
Fig. 1
Spritztube tracheal cannula. (a) Spritztube assembled for insertion, note distal (white arrow) and proximal (black arrow) cuffs inflated for
demonstration purpose. (b) Distal (white arrow) and proximal (black arrow) cuffs. (c) Pilot balloons of distal (black arrow) and proximal (white arrow)
cuffs.
Eur J Anaesthesiol 2019; 36:955–962
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down to the hypopharynx. The Spritztube can be
inserted blindly or with the aid of direct or indirect
laryngoscopy or rigid or flexible endoscopes (Figs. 1
and 2). More information about the device and the
insertion technique can be accessed at http://www.spritz-
tube.eu/en/details.
To date, the Spritztube is not commercially available
and is only for experimental use. The only published
report on the Spritztube is a recent mannequin-
based study demonstrating a higher successful inser-
tion rate and ease of use compared with the LMA
Fastrach.5
We designed a randomised controlled trial to compare the
LMA-S and Spritztube performance in a cohort of
mechanically ventilated patients undergoing elective
surgery in the supine position. We hypothesised that
the Spritztube is as effective as the LMA-S in maintain-
ing the airway.
Methods
The current study was approved by the ethics committee
of St. Bortolo Hospital, Vicenza, Italy (29/16) in accor-
dance with the principles outlined in the Declaration of
Helsinki and registered (NCT03443219). We obtained
written informed consent from all patients enrolled in
the study.
 LMA Supreme vs. Spritztube 957

Fig. 2

(a) Spritztube assembled as if in tracheal position; note the removed stilette and the distal tip below and above Spritztube respectively. (b) Detail of
the tip with the oesophageal segment still connected to Spritztube by the stilette.

American Society of Anesthesiologists’ (ASA) physical
status classification 1, 2 or 3 patients scheduled for
elective surgery in the supine position were considered
eligible.
Before arrival in the operating room, and after the collec-
tion of written informed consent, patients were randomly
assigned to LMA-S or Spritztube group by opening an
opaque sealed envelope with their number of randomisa-
tion order, provided by an independent physician blinded
to the patient’s allocation, who also recorded successful
placement, time taken for insertion and complications at
insertion or removal.
The general anaesthesia protocol, intra-operative moni-
toring and postoperative care performed for all patients
was standardised and managed by an independent anaes-
thetist not directly involved in the study, and included
HR, peripheral oxygen saturation and continuous electro-
cardiography. All patients received premedication with
midazolam 0.03 mg kg1 followed by fentanyl 2 mg kg1
and propofol 2 mg kg1 for induction of anaesthesia.
Anaesthesia was maintained with propofol (continuous
infusion 6 to 8 mg kg1 h1) and remifentanil (continuous
infusion 0.25 to 0.75 mg kg1 min1). Neither nitrous
oxide nor a neuromuscular blocking agent were given,
and depth of anaesthesia was monitored with the bispec-
tral index (BIS monitor; Covidien Medical, Louisville,
Colorado, USA), targeting the range 40 to 60. Both the
LMA-S and the Spritztube were inserted by trained
anaesthesiologists with at least 5 years of experience.
The size of the LMA-S was chosen according to the
patient’s weight and ranged from size 3 (30 to 50 kg)
through 4 (50 to 70 kg) to 5 (70 to 100 kg). The Spritztube
is available in a unique adult size.
The Spritztube was inserted blindly into the oropharynx
using the following method. Before insertion, the cuffs
were deflated and a water-soluble lubricant was applied
to the cuffs. The patient’s neck was extended to the
‘sniffing position’. Held as a pen, the device was inserted
into the oral cavity following the soft palate, stopping
introduction once the black marker on the Spritztube
(teeth mark) reached the upper incisors. Then, distal and
proximal cuffs were inflated with 20 and 60 ml of air,
respectively. The stilette was then removed and the tube
was connected to the breathing circuit or to a bag-valve
assembly.5
The LMA-S was inserted completely deflated and lubri-
cated using the recommended technique.4–7
The insertion time was measured with a stopwatch by an
independent observer, from the start of insertion of the
device into the patient’s mouth until connecting the
breathing circuit; the cuff pressure was set at 60 cmH2O
once the device was inserted. Successful placement was
defined as adequate patient ventilation after supraglottic

Eur J Anaesthesiol 2019; 36:955–962

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 958 De Rosa et al.
airway device placement and was assessed considering
the presence of regular and repeated end-tidal carbon
dioxide waveforms and chest movement without audible
leaks after gently squeezing the reservoir bag. In the
event of supraglottic airway device placement failure, two
more attempts at insertion of the device were allowed,
then the supraglottic airway device placement was con-
sidered to have failed and the patient’s trachea was
intubated. A bubble-test was performed and a gastric
tube was placed through the gastric port of the LMA-S, as
correct position confirmatory tests (drain tube leak test
and gastric tube placement).4 Mechanical ventilation was
in volume control mode with a fraction of inspired
oxygen ¼ 0.35, an inspiratory–expiratory ratio of 1 : 2, a
targeted tidal volume of 6 to 8 ml kg1, a positive end-
expiratory pressure of 4 to 8 cmH2O, and a frequency set
to keep the end-tidal carbon dioxide tension between 4.0
and 4.7 kPa (30 and 35 mmHg). The presence or absence
of gastric insufflation was then detected by auscultation
over the epigastrium, and through air leak evaluation on a
ventilator spirometer (FLOW-i; Maquet, Solna,
Sweden), and determined by the difference between
the inspired and expired tidal volumes on an average
of three mandatory breaths (the presence of air leak was
considered if there were differences >20% of the preset
tidal volume).8 Expiratory tidal volume, and peak and
plateau inspiratory pressures, were also collected at base-
line (skin incision), 15, 30, 45 and 60 min directly from
data displayed on the ventilator screen. The anaesthetic
procedure was then completed with the LMA-S
or Spritztube.
The sample size was calculated considering the reported
incidence of successful insertion of the LMA-S (92%) and
the expected rate of successful insertion of the Spritztube
(99%). Starting from these data and considering an A/Z
test (or x2 test) for comparison of proportions from
independent samples with a ratio M/N ¼ 1/1, the sample
size resulted in at least 137 patients in each group for two-
sided tests with type I error of 5% and power of 80%.
The primary outcome was the successful placement rate
of the airway device. Secondary outcomes were insertion
time, number of attempts, subjective assessment of ease
of insertion, the number of complications at insertion (air
leak, laryngospasm, obstruction after induction, blood-
staining, gastric insufflation device failure) and symptoms
after removal (dysphagia, hoarseness and sore throat). We
also investigated the presence of a relationship between
predefined variables [age; BMI; BSA; thyromental dis-
tance (TMD); inter-incisor distance (IID); Mallampati
score; El-Ganzouri risk index; neck mobility; ASA physi-
cal status; presence of prognathism; any previously
reported difficult intubation] and two separate dependent
variables (the presence of at least one complication and
the time needed to perform the device placement).
Respiratory parameters (expiratory tidal volume, peak
inspiratory pressure and plateau inspiratory pressure)
Eur J Anaesthesiol 2019; 36:955–962
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were also collected at predefined time-points during
anaesthesia.
Statistical analysis
Data distribution was evaluated by means of the one-
sample Kolmogorov–Smirnov test. Continuous variables
are presented as mean  SD or median [IQR] as appro-
priate. The primary outcome was ascertained by means of
the comparison between the percentage of successful
placements of the LMA-S vs. the Spritztube using the
x2 test. Secondary outcomes were evaluated according to
variable type as following: differences between the
LMA-S and Spritztube groups for continuous variables
were assessed using Student’s t test or Mann–Whitney U
test according to normal or nonnormal distribution,
respectively; for dichotomous or categorical variables,
the x2 test for comparison of proportions was applied.
Four different stepwise logistic regression analyses
(backward stepwise method based on likelihood) were
also calculated to investigate a potential relationship
between the presence of at least one complication
(dependent variable 1) or time for device placement
(dependent variable 2) separately both for LMA-S and
Spritztube. The predefined variables included in the
model as independent variables for both devices and
both dependent variables were: age, BMI, BSA, TMD,
IID, Mallampati score, El-Ganzouri risk index, neck
mobility, ASA physical status, presence of prognathism
and any previously reported difficult intubation. All the
nondichotomous variables were computed as dichoto-
mous according to the following cut-off points: for cate-
gorical variables based on clinical indication
(BMI > 25 kg m2, Mallampati score > 2, El Ganzouri
risk index  4, neck mobility > 1, ASA physical
status > 2); for continuous variables (time for device
placement, age, BSA, TMD, IID) based on the median
value of the study population. The results were reported
as the odds ratio (OR) and 95% confidence intervals. For
all tests, the null hypothesis was rejected for P values less
than 0.05. Data were analysed using MedCalc Statistical
Software version 13.0 (MedCalc Software bvba, Ostend,
Belgium).
Results
Of the 355 enrolled patients, 334 were randomised to
either the LMA-S or Spritztube group (Fig. 3). Demo-
graphic, anaesthesiological and surgical characteristics are
shown in Table 1.
The Spritztube was placed correctly in all the patients
enrolled (100%), while the LMA-S was correctly placed
in 94.6% of patients (P ¼ 0.006).
Insertion time was not significantly different between
LMA-S and Spritztube groups (10 [10 to 20] vs. 10 [10 to
15] s, respectively; P ¼ 0.06). Subgroup and single com-
plication data are shown in Table 2. Overall, the rate of
complications was higher in the LMA-S group compared
 LMA Supreme vs. Spritztube 959

Fig. 3

Enrolment
Assessed for eligibility (n = 355)

Excluded (n = 21)
Not meeting inclusion criteria (n = 8)
Declined to participate (n = 10)
Other reasons (n = 3)

Randomised (n = 334)

Allocation
Allocated to LMA-S group (n = 167) Allocated to Spritztube group (n = 167)
Received allocated intervention (n = 158) Received allocated intervention (n = 167)
Did not receive allocated intervention) (n = 9) Did not receive allocated intervention (n = 0)
o failure of insertion

Follow-up
Lost to follow-up (n = 0) Lost to follow-up (n = 0)

Discontinued intervention (n = 0) Discontinued intervention (n = 0)

Analysis
Analysed (n = 158) Analysed (n = 167)

Flowchart of study design.

with the Spritztube (19.1 vs. 6.0%; P < 0.001). In the
subgroup analyses, the LMA-S was associated with a
higher rate of complications at anaesthesia induction
(18.0 vs. 5.3%, P < 0.001), but not at removal (1.2 vs.
0.6%, P ¼ 0.99). Device failure and blood-staining were
observed more often in the LMA-S group than the
Spritztube group (5.4 vs. 0%, P ¼ 0.006 and 3.6 vs. 0%,
P ¼ 0.04). No differences were found in volume or pres-
sure variables during anaesthesia between the LMA-S
and Spritztube groups.
In both LMA-S and Spritztube groups, none of the
variables included in the logistic regression model was
associated with complications. In the LMA-S group, age
(directly) and prognathism (inversely) were associated
with longer time of insertion [OR 1.04 (1.01 to 1.06),
P ¼ 0.003, and 0.42 (0.18 to 0.98), P ¼ 0.04, respectively].
Conversely, in the Spritztube group, the TMD was
related inversely to longer time of insertion [OR 0.30
(0.11 to 0.82) P ¼ 0.02].
Discussion
This is the first randomised prospective study comparing
the Spritztube and LMA-S in anaesthetised adult
patients. Our study showed that the Spritztube was as
effective as the LMA-S in maintaining the airway with all
patients’ lungs being ventilated safely and successfully.
The success rate of achieving a patent airway was com-
parable between the groups (LMA-S 94.6% vs. Spritz-
tube 100%), with less complications in the Spritztube
group (10.6 vs. 19.1%; P < 0.001). The success rate of the
LMA-S was in line with data from the literature9,10 and
the two groups enrolled were basically comparable
because difficult airway management was excluded by
screening according to SIAARTI (Italian Society of

Eur J Anaesthesiol 2019; 36:955–962

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 960 De Rosa et al.

Table 1 Demographic data

LMA-S, N U 158 ST, N U 167 P

Age (years) 57 [45 to 68] 60 [48 to 69] 0.35
Sex (male : female) 31 : 136 43 : 124 0.08
BMI > 25 kg m2 77 (46.1%) 79 (47.3%) 0.91
ASA class
1/2 152 (91) 157 (94%) 0.40
3/4 15 (9%) 10 (6%) 0.40
Mallampati class >2 16 (9.6%) 21 (12.6%) 0.49
Thyromental distance (cm) 0.001
>6.5 0 (0%) 0 (0%)
6.0 to 6.5 166 (99%) 162 (97%)
<6.0 1 (1%) 5 (3%)
Mouth opening (cm) 0.05
>4 89 (53%) 74 (44%)
4 78 (47%) 93 (56%)
Uncorrectable maxillary prognathism 42 (25.1%) 22 (13.2%) 0.008
Positive history of difficult intubation 0 [0%] 0 [0%] NA
Neck mobility > 1 157 (94%) 154 (92.2%) 0.66
El-Ganzouri index  4 37 (22.2%) 48 (28.7%) 0.22
Type of surgery
Breast 56 (33.5%) 59 (35.3%) 0.81
Gynaecological 46 (27.5%) 32 (19%) 0.09
Abdominal 10 (5.99%) 28 (17%) 0.003
Urological 10 (5.99%) 19 (11%) 0.15
Bariatric 0 (0%) 1 (0.6%)a 0.99
Ear, nose and throat 0 (0%) 3 (1.8%) 0.24
Maxillofacial 0 (0%) 1 (0.6%) 0.99
Plastic 38 (22.7%) 12 (7%) <0.001
Neurosurgery 0 (0%) 8 (5%) 0.01
Vascular 2 (1.2%) 4 (2.4%) 0.68
Laparoscopic 1 (0.6%) 0 (0%) 0.99
Ophthalmic 1 (0.6%) 0 (0%) 0.99
Orthopaedic 3 (1.8%) 0 (0%) 0.24
Duration of anaesthesia (min) 40 [20 to 60] 30 [20 to 50] 0.04

Values are number, number (%) or median [IQR]. ASA, American Society of Anesthesiologists’ physical status; LMA-S, Laryngeal Mask Airway Supreme; ST, Spritztube.
a
One patient with BMI < 28 kg m2, previously treated for bariatric procedure and undergoing surgical scar revision.

Anaesthesiology, Analgesia Reanimation and Intensive
Care) 2005 guidelines.6
Overall, there were no significant differences between
the groups at baseline. Although TMD, uncorrectable
maxillary prognathism and duration of anaesthesia were
different in the two groups, these differences appear to
have low clinical relevance in consideration of the study’s
objective. The same consideration applies to differences
in the type of surgery. In our study, the time necessary for
Spritztube insertion was not significantly shorter when
compared with the LMA-S. Nevertheless, both insertion
times were shorter and faster than reported in other
studies,9,11 probably because all physicians involved in
the study had considerable experience of supraglottic
airway device placement. In addition, the first attempt
and overall insertion success rates for the Spritztube were
significantly higher than for the LMA-S (P ¼ 0.0007). We

Table 2 Complications

LMA-S ST P
Complication at insertion Air leak at induction 9 (5.4%) 3 (1.8%) 0.14
Laryngospasm 0 (0%) 2 (1.2%) 0.48
Obstruction after insertion 5 (3%) 3 (1.8%) 0.72
Blood-staining 6 (3.6%) 0 (0%) 0.04
Presence of gastric insufflation 1 (0.6%) 1 (0.6%) 0.48
Device failure 9 (5.4%) 0 (0%) 0.006
Any complication at insertion 30 (18.0%) 9 (5.3%) <0.001
Complication at removal Dysphagia 1 (0.6%) 0 (0%) 0.98
Hoarseness 0 (0%) 0 (0%) NA
Sore throat 1 (0.6%) 1 (0.6%) 0.47
Any complication at removal 2 (1.3%) 1 (0.6%) 0.94
Total complications 32 (19.1%) 10 (6.0%) <0.001

Values are number (%). LMA-S, Laryngeal Mask Airway Supreme; ST, Spritztube.

Eur J Anaesthesiol 2019; 36:955–962

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do not believe that our results indicate a significant
clinical difference in terms of time of positioning
between the Spritztube and the LMA-S, whereas our
data might suggest that the Spritztube might be useful as
a rescue device in emergency conditions.
The LMA-S and Spritztube reflect two different
approaches to supraglottic airway device placement. As
for the original LMA Classic and LMA-like devices,3
LMA-S insertion requires sliding of the supraglottic
airway device along the anatomical curve of the orophar-
ynx and hypopharynx. The ease of insertion and insertion
time may be influenced, given the same experience of the
operators, by lubrication, tongue/oropharynx ratio and
correct size choice. There is still debate as to whether
the weight-based sizing policy is suitable or correct,2 and
any data on insertion time and perceived ease should be
interpreted cautiously. Insertion of the Spritztube is
similar to that of the ‘Combi’-like devices,3 with a (gen-
erally) stiffer and smaller diameter device pushed blindly
towards the oesophagus with minor need to adapt to
physiological upper airway curves, compared with
LMA-like devices. This concept should make the Spritz-
tube and ‘Combi’-like device insertion faster, whereas
data from the literature express contradictory results.12–14
However, subjective perception of ease of insertion
seems to be generally higher for ‘Combi’-like devices.
In our study, participating physicians were advanced
Spritztube users, obtaining fast insertion times also in
patients in whom logistic regression showed a higher
incidence of anatomical factors potentially making the
Spritztube group airways more difficult than in the LMA-
S group.
There was a significant difference between the two
groups in respect of the patients’ characteristics (Table
1) concerning the Mallampati class, TMD, uncorrectable
maxillary prognathism and El-Ganzouri index, which
were significantly higher in the Spritztube group. The
logistic regression analysis showed that increased time of
insertion of the LMA-S was directly related to the age of
the patient and the presence of prognathism. A recently
published retrospective study on almost 20 000 cases of
supraglottic airway device placement found a global
supraglottic airway device failure rate of 1.9%15 and
identified different factors associated with supraglottic
airway device failure. Our study showed a higher failure
rate for the LMA-S, even though none of the factors
indicated by Vannucci et al.15 was observed in our patient
sample. Conversely, in the Spritztube group, increased
time for insertion was directly related only to a large
TMD. A possible explanation for this finding is that a
longer time is necessary to reach the final oesophageal
position of the Spritztube tip in a longer neck, consider-
ing that the LMA-S has been demonstrated to penetrate
deeper than other supraglottic airway devices in the
upper oesophageal sphincter.16
Eur J Anaesthesiol 2019; 36:955–962
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LMA Supreme vs. Spritztube 961
In our study, we assessed intra-operative and postopera-
tive complications. Concerning complications at inser-
tion, the occurrences of blood-staining and device failure
were significantly higher in the LMA-S group. The
incidence of these two complications is quite common
after LMA-S insertion, as shown in other studies.17,18
Compared with the Spritztube, the LMA-S is somewhat
bulkier, has a different insertion technique and a certain
tendency for the tip to flip,9 all factors which might
increase the risk of insertion-related minor trauma to
the upper airway. In the Spritztube group, the lower
occurrence of blood-staining could be attributed to dif-
ferent elasticity of the constructive material (silicone) of
the Spritztube compared with the stiffer PVC of the
LMA-S; the silicone elastomer cuff probably allows bet-
ter oropharyngeal adaptability, thus minimising tissue
trauma. Finally, there might be a different pattern of
eventual bleeding deposition, as the larger cuff of the
LMA-S positioned in the hypopharynx, could collect
more blood than the rounded (and deflated) cuff of the
Spritztube (which remains located more cranially) at the
time of removal.
The incidences of dysphagia, hoarseness and sore throat
at removal were comparable in the two groups. The
LMA-S and the Spritztube cuffs lie in different positions
in the upper airway, and despite a longer mean duration
of anaesthesia in the LMA-S group, no oropharyngeal
symptoms were observed. This might also be due to the
cuff pressure monitoring policy which was adopted in the
study, and to the experience of the investigators, as these
have been shown to be factors involved in the genesis of
oropharyngeal symptoms.19
There are a number of limitations of our study. First, our
patients were anaesthetised, and volume control venti-
lation was used without paralysis. Although we moni-
tored the depth of anaesthesia with a BIS monitor, the
absence of neuromuscular blocking agents might also
affect the ease of insertion and eventual oropharyngeal
symptoms because of cricopharyngeal muscle and upper
oesophageal sphincter activity.19 Second, the oropha-
ryngeal leak pressure was not measured at the start of
the procedure and over time, meaning that we might
have a snapshot of the devices’ performance but not an
overall evaluation. Third, we did not perform fibreoptic
inspection through the airway device to visualise the
laryngeal inlet and the device positioning, as other
studies have done.14 In addition, we included patients
undergoing many different surgical procedures, but we
considered that because the study’s endpoints were
successful insertion, safety and complication rates, this
was only a potential bias while it allowed faster and
wider sample population enrolment. A further bias in
our study could be the extensive of the Spritztube at our
centre, and our results might not be reproduced else-
where until after an adequate learning curve with
the device.
 962 De Rosa et al.
Conclusion
In this clinical randomised trial comparing the LMA-S
and Spritztube tracheal cannula, the new device seems to
be a safe, effective and easy-to-use disposable supraglot-
tic airway device, showing performance and reliability not
less than the LMA-S. Further studies, to be conducted on
larger numbers of patients and comparing with different
supraglottic airway devices, are necessary to assess effi-
cacy and performance of the Spritztube and to define an
adequate learning curve.
Acknowledgements relating to this article
Assistance with the study: The authors wish to thank Fiorenza
Ferrari for statistical assistance and sample size calculation at the
beginning of study protocol. In addition, the authors thank Saher
Abd Elghani, Desiderio Bonaventura, Elisa Boni, Vito Cirillo,
Fiorenza Ferrari, Cecilia Maietti, Pierluigi Marranconi, William
Miglioranza and Mirco Primadei, Maurizio Scollo from the Depart-
ment of Anaesthesiology and Intensive Care, San Bortolo Hospital,
Vicenza, Italy for valuable support, participation, advice and help.
Financial support and sponsorship: none.
Conflicts of interest: SCC is the inventor of the Spritztube that is
marked CE. There is no financial or personal relationship with people
or organisations that could inappropriately influence the work. MS
participated at research, development and preclinical testing of the
LMAProtector, and has paid consultancies with Teleflex Medical,
Dublin, Ireland and DEAS, Castelbolognese, Italy.
Presentation: none.
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